BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ MRI IPG

    MDR report key: 9109859 · Received September 24, 2019

    Report

    Report Number
    3006705815-2019-03563
    Event Type
    Injury
    Date Received
    September 24, 2019
    Date of Event
    June 14, 2017
    Report Date
    September 24, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017086
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2017-04614, 3006705815-2019-03564. IT WAS REPORTED THAT THE PATIENT HAD THEIR CERVICAL SYSTEM EXPLANTED ON (B)(6) 2018. P010032.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903881 PROTÉGÉ MRI IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3771 5422902 05415067017086

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other SCS IPG| SCS LEAD